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Intercept Pharmaceuticals Reports Second
Quarter 2019 Financial Results
and Provides Business Update
delivers strongest quarter to date with worldwide Ocaliva® net sales of $65.9
million in the second quarter of 2019, representing 53% growth versus the prior year quarter
NDA filing for NASH on track for third quarter of 2019; EU MAA filing for NASH
projected for fourth quarter of 2019; NASH launch preparations accelerating
industry-leading NASH clinical development program;
Completed target enrollment for the clinical outcomes cohort of the Phase 3 REGENERATE
study, with more than 2,400 patients randomized
Conference call scheduled for 8:30 a.m. ET today
NEW YORK, August 7, 2019 – Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced its financial results for the quarter ended June 30, 2019 and provided an update on its industry-leading nonalcoholic steatohepatitis (“NASH”) clinical development program.
“We are pleased with our team’s outstanding commercial execution in the second quarter, as we continued to gain traction with community gastroenterologists and drove growth in our PBC business,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “We’ve also made significant progress in our NASH launch preparations and remain on track to submit our NDA to the FDA seeking accelerated approval of OCA for NASH in the U.S. later this quarter. We have established a strong commercial foundation in PBC and continue to believe that advanced fibrosis due to NASH represents a blockbuster opportunity. Recent changes in the competitive landscape and the insights we’ve collected from physicians, payers and patients have reinforced our conviction that OCA, if approved, is in a unique position to address the significant unmet medical need for an antifibrotic therapy intended to treat this serious disease.”
NASH Clinical Development Program Updates
Intercept’s lead product candidate is obeticholic acid (“OCA”) for the potential treatment of NASH. In February 2019, Intercept announced positive topline results from the 18-month interim analysis of its pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH. This was the first successful Phase 3 study readout in this patient population and the results are intended to serve as the basis for seeking accelerated approval in the U.S. and submitting a marketing authorization application (“MAA”) in Europe.
The REGENERATE study is planned to continue to confirm benefit on clinical outcomes on a post-marketing basis and Intercept has now completed target enrollment for the clinical outcomes cohort of REGENERATE. The end-of-study analysis will evaluate the effect of OCA on all-cause mortality and liver-related clinical outcomes, as well as long-term safety. With more than 2,400 patients randomized, the REGENERATE study is the largest and most advanced Phase 3 study in patients with liver fibrosis due to NASH.
The following information was filed by Intercept Pharmaceuticals, Inc. (ICPT) on Wednesday, August 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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